光纤过程监测美洛昔康及头孢拉定分散片的溶出度  

In situ fiber optic process dissolution monitoring of meloxicam dispersible tablets and cefradine dispersible tablets

作　　者：曹红[1] 陈坚[1] 熊海疆 刘亚婷[1] 

机构地区：[1]新疆医科大学药学院 [2]新疆富科思生物技术公司,乌鲁木齐830011

出　　处：《药物分析杂志》2007年第8期1281-1284,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家科技部中小企业创新基金(03C26216500443)

摘　　要：目的:使用新疆富科思生物技术公司-新疆医科大学联合研制的101型光纤药物溶出过程监测仪,原位、实时监测美洛昔康及头孢拉定分散片的溶出曲线,以评价其性能、特点。方法:(1)设定测定波长362 nm、基线校正波长450 nm、温度37℃、转速75 r·min^(-1)、数据采集间隔30 s、监测时间20 min,以1000 mL 磷酸盐缓冲液(pH 7.8～8.0)为溶出介质,桨法,用光程为1 cm 的光纤探头监测美洛昔康分散片的溶出曲线;(2)设定测定波长255 nm、基线校正波长450 nm、、温度37℃、转速100 r·min^(-1)、数据采集间隔30 s、监测时间45 min,以900 mL0.1 mol-L^(-1)盐酸溶液为溶出介质,桨法,用光程为2 mm 的光纤探头监测头孢拉定分散片的溶出曲线。结果:美洛昔康及头孢拉定分散片的实时溶出曲线反映出药物分别在前3～5 min 释放很快,美洛昔康分散片20 min 的溶出度>70%,头孢拉定分散片45 min 的溶出度>85%,均符合国家原品标准的规定。结论:101光纤药物溶出过程监测仪原位、实时、连续、定量地反映了美洛昔康及头孢拉定分散片溶出迅速的特性,经自身对照和基线校正,获得的数据信息更加完整、真实、准确,相应软件的使用实现了分散片体外溶出过程监测的自动化、智能化。Objective： The fiber- optical pharmaeeuties dissolution process monitor （FODM） was used in this study to demonstrate the dissolution behavior of meloxicam dispersible tablets and cefradine dispersible tablets and evaluate the utility of FODM. Methods： （ 1 ） Meloxicam dispersible tablets was monitored with 1 cm fiber optic probe. The dissolution conditions were：1000 mL of phosphate buffer at pH 7.8 -8.0, paddle at 75 r·min^-1. The fiber optic unit was configured to calculate the amount of drug dissolved by substraeting the baseline measurement, 450 nm,from the peak measurement at 362 nm. Dissolution data were collected and plotted as% -dissolved every 30 seconds during 20 min run. （2） Cefradine dispersible tablets was monitored with 2 mm fiber optic probe. The dissolution conditions were：900 mL of 0. 1 mol·L^-1 HCl, paddle at 100 r·min^-1. The fiber optic unit was configured to calculate the amount of drug dissolved by subtracting the baseline measurement,450 nm, from the peak measurement at 255 nm. Dissolution data were collected and plotted as% - dissolved every 30 seconds during 45 min run. Results：The dissolution curve of meloxicam dispersible tablets and cefradine dispersible tablets indicate the two products are almost completely dissolved 3 -5 min from the start of the experiment,respectively. Dissolution of the two dispersible tablets accord with the regulation of district standard updating as national standard. Condusion：FODM offers the advatage of very high data density when monitoring in real - time the dissolution profile of immedia release solide dose formulations. The inherent challenge to in situ measurements is the obvious lack of illtration before mesurement. However, the effect of particle undissolved and pharmaceutical excipients is largely eliminated when controlling serf and baseline correction treament are used in quantitation.

关 键 词：美洛昔康 头孢拉定 分散片 光纤药物溶出过程监测仪 溶出度 

分 类 号：R917[医药卫生—药物分析学]